Treating Resistant Hypertension: Renal Denervation, life style changes Vs Dangerous Coupling or COUPLER device to connect Art & Vein Blood FLOW

Resistant Hypertension: Renal Denervation, life style changes Vs Dangerous Coupling  or COUPLER device to connect Art  & Vein blood FLOW.

 

 

Hypertension can usually be controlled with medication and lifestyle changes. On the other hand, up to one in 10 people have resistant hypertension that doesn't respond well to blood pressure medications  and 1in 20 who do not respond to any kind of medication. For these people, there may be a new treatment alternative. According to new research published in the journal Lancet, a minimally-invasive procedure that uses radiowaves could help people with drug-resistant hypertension get their blood pressures under control.

Better New Way to Treat Resistant Hypertension?

 

This blood pressure-lowering procedure called renal denervation, or RND, involves inserting a catheter into a groin artery and guiding it into the renal artery that leads to the kidney. Once it reaches the renal artery, the catheter is programmed to put out bursts of radio waves. These radiowaves inactivate small nerves that lie over the renal artery. These nerves stimulate the kidneys to produce hormones that raise blood pressure.

 

RND for Drug-Resistant Hypertension: The Bottom Line?

This is an exciting new development for people who are unable to control their blood pressures through conventional means. Stay tuned for more research about this new treatment for resistant hypertension.

Two companies are at the forefront of it.  Ardian Medical now Medtronic  and Vessix Medical now part of Boston Sci. The market is $2 Billion worldwide.

US represent approx 1/3 of the market.

AMA: Recommends some guidelines. The first step is to determine whether a person actually has resistant hypertension, which isn't the same as uncontrolled hypertension, the committee said. Successful treatment of resistant hypertension requires consideration of lifestyle factors that contribute to the problem, diagnosing and treating secondary causes, and using multiple drug treatments effectively.

Lifestyle factors noted by the AMA committee included weight, salt intake and alcohol consumption. Obesity is associated with more severe blood pressure and losing weight can lower blood pressure and reduce the number of medications needed to control blood pressure. High dietary salt intake is common among patients with resistant hypertension. In patients with general high blood pressure, reducing salt intake can lower blood pressure. Heavy alcohol intake is also associated with resistant hypertension.

The committee also listed a number of health conditions that can contribute to resistant hypertension. They include: obstructive sleep apnea, renal parenchymal disease, primary aldosteronism and renal artery stenosis. Treating these conditions may improve blood pressure control.

Medications were the third area covered by the committee. They said the use of drugs that increase blood pressure, such as non-steroidal anti-inflammatory drugs (NSAIDs), should be reduced or halted, if possible, in patients with resistant hypertension.

The committee noted that diuretics are often underused in people with resistant hypertension. They also said some patients may benefit from adding mineralocorticoid receptor antagonists (MRAs) to their treatment regimens. MRAs treat primary aldosteronism, which is found in about 20 percent of people with resistant hypertension.

"The benefit of mineralocorticoid receptor antagonists in treating resistant hypertension has only been recently confirmed," writing committee chair Dr. David A. Calhoun, a professor of medicine in the Vascular Biology and Hypertension Program at the University of Alabama in Birmingham, said in a prepared statement.

Possible Risks associated with Vascular treatments using COUPLER or Coupling Device to connect Artery & Vein FLOW!!

Health care professional have to be careful of using technologies that are not proven. For example the risks associated with devices in clinical trials like arterio-venous COUPLER or coupling devices or shunts that divert the high pressure arterial blood FLOW into the veins.  Experts suggest that this procedure is going to increase more pressure in the veins and load on the Right side of the heart possibly adding a risk for Right Heart Failure. Causes increased venous statsis, lead to venous ulcers, incompatible venous valves, swelling of the leg, reducing mobility in obese patients, and we can go on and on, increased cardiac output, heart rate.  "I would not touch this artery to vein coupling  procedure as a physician or as a patient. We have better choices!! "said one expert.
Another risk associated with this procedure is ‘the procedure itself”. Poking the artery and letting it bleed until you connect it to a vein is unimaginable in this day an age. Very barbaric, thinking of this procedure makes me hypertensive, you can bleed profusely in a high pressure system and harm vital organs, induce portal hypertension, reduced supply to your genital area ...can it possibly cause erectile dysfunction with a coupling device to treat drug resistant hypertension . To top it all the procedure may be done with more guess work and experience (many doctors work with arteries in flouroscopy, with vein its hard to work with!! In the cath lab. Those who are in interventional cardiology will get it!! Some doctors are enthusiastic to see “what happens”. This coupling devices to treat hypertension is way "TOO RISKY” and “absolutely useless"  vs the more proven minimally invasive renal denervation and another 100 medical devices in this space. Another aspect of this coupling device is that this device cannot be removed, so not technically non-removable, if you want to reverse the effect you might have to patch the hole in the artery..the long term risk may out weigh the tiny benefit and potential for a post market liability from a corporate perspective, distributor or physician perspective.

Business of Obesity: Top innovations in Obesity and Diabtes

Obesity and Diabetes Treatment, Innovation and Prevention Summit

Attend the first Obesity and Diabetes Treatment, Innovation and Prevention Summit

This is a great opportunity for health care professionals including physicians, nutritionist, nurses, hospital administrators, research professionals, scientist, policy makers, insurance providers, group purchasing organizations, non profits foundations, start ups and mature companies wanting to learn about prevention, identification and treatment of obesity. This event will bring, key opinion leaders to talk about various methods to identify, manage, treat and prevent obesity and diabetes. Twenty innovative companies working in obesity and diabetes will showcase their technologies to attendees so the community is aware of the next generation technologies available to their patients and future developments. Strategic companies can take advantage of this summit. ODIS is the first of its kind obesity and diabetes summit held on the west coast.

When:  Jan 30 -31, 2014

Where: Westin, South Coast Plaza in Orange County, CA.  

To attend contact: Info.odis1@gmail.com

Orange County is known as a hub for medical device innovation.  This event will elevate the visibility of Southern California and innovative companies in the fight against obesity and diabetes. 

 In July 2013 the American Medical Association declared that obesity was a disease.  Obesity and related healthcare issues cost the US $190 Billion annually. This is an important time in the fight against obesity and diabetes

To sponsor, showcase or qualify to present please email a non-confidential company profile to info.odis1@gmail.com

Top 20 in the obesity and diabetes space will be presenting at the innovation summit.

Obesity and Diabetes Innovation Summit is being presented by TrialMed Life Sciences and SEVEN (Scientific Entrepreneur & Venture Capital Network). 

 

China to Boost Innovative Medical Device Industry- Investors start exploring the space

China to Boost Innovative Medical Device Industry

Irvine, CA:With growing need for medical technology and view to support the development of the innovative medical device industry in China, China’s Food and Drug Administration (CFDA) released the “Special Review and Approval Process for Innovative Medical Devices (Draft) (hereinafter referred to as ‘Draft’)” on March 20, which increases the efficiency of the review and approval process for innovative medical devices. Detailed information can be found below.

The Draft

Eligibility Requirement

To qualify for the special review and approval process, an applicant and its products must satisfy the following requirements:

• The applicant shall own independent intellectual property rights to the medical device, meaning the applicant must be either the owner or the licensee of Chinese invention patents.
• The primary functioning mechanism of the medical device shall be the first of its kind in China, and the device’s efficacy or safety profile shall be fundamentally improved as compared with other similar products.
• The medical device shall have significant clinical application value.
• The applicant shall have completed the initial R&D stage and have developed a basic prototype; the research process shall be authentic and under control, with the research data being complete and traceable.

Moreover, the applicant must be a legal entity in China (including wholly-foreign owned enterprises and Sino-foreign joint ventures), possess a valid medical device manufacturing license, and the relevant products must be manufactured in China

Application Process

For applicants intending to engage in the special review and approval process, they shall file an application with the provincial food and drug administration (Provincial FDA). The Provincial FDA will then conduct a preliminary review and submit the application together with its preliminary opinions to the CFDA for final approval.

Once the application has been approved, the CFDA and the Provincial FDAs will give priority to such application in the entire approval process. In addition, both the CFDA and Provincial FDAs are required to communicate with and provide guidance to the applicant in a timely manner, including appointing a special government liaison for the applicant and establishing formal communication channels.

The Circular

Apart from the efforts to improve the efficiency of the review and approval process for medical devices, the CFDA also intends to simplify the application materials required in the license re-registration process for medical devices.

In China, the medical device license is only valid for four years, and requires renewal prior to expiration. The regulation, named “Circular on Simplifying Application Materials Required for Medical Device License Re-registration (Draft) (hereinafter referred to as ‘Circular’)”, has offered a more streamlined re-registration process to help relieve medical device manufacturers from the tedious re-registration process.

According to the Circular, where there have been no material changes in the efficacy or safety profile of the medical device, the applicant no longer needs to provide the operation manual, product standards, and test reports.

Where there have been changes to the manufacturing address or the product’s model, specification, product standards, functional structure or components, the applicant only needs to provide technical documents relevant to the changes. The submission of the operation manual, product standards, and test reports is no longer required.

However, where there have been significant changes to the product structure and design, major material alterations, or other significant changes that may affect product safety and efficacy, a new product registration is still required.

Biggest market in the health care space: North American Obesity Market to Swell to $139.5B by 2017, Spells Opportunity for Device Makers

Find more content on:

• Medical Device Business
• Courtesy: Arundhati Parmar

North American Obesity Market to Swell to $139.5B by 2017, Spells Opportunity for Device Makers

A new research report forecasts that the weight loss and obesity management market in North America will increase to $139.5 billion in 2017, up from $102 billion in 2012.

The market includes medical device products used in weight loss surgery, and the report from MarketsandMarkets underscores the opportunity for medical device manufacturers. In the medical device arena, the opportunity seems to be primarily in areas that provide patients an alternative to invasive surgery. The report said:

Minimally-invasive and non-invasive surgical procedures that use highly sophisticated equipment like endoscopes and laparoscopes have been developed. In addition, non-invasive weight loss techniques like cryolipolysis, transoral obesity revision surgery, cold laser shaping, and Stomaphyx are also gaining popularity.

It remains to be seen whether American Medical Association's decision to consider obesity a disease will have an effect on the overall size in the market. When the June decision from the AMA came down, it marked a real uproar because some believed that considering obesity a disease basically means that individual responsibility can be denied. People who lead unhealthy lifestyles can simply believe that clinical intervention is automatically required instead of a change in behavior.
The same debate has spilled over to a discussion on the LinkedIn Medical Devices Group. Politics aside, what is salient about the discussion is that some users of the group believe the growing market holds great promise for medical device inventors.
Take user Paul Stein for instance. A medical device professional, formerly with St. Jude Medical, Stein believes that medical devices will succeed in tackling the epidemic that is obesity where pharmaceutical companies have failed. Here is an edited version of his comments:

For us in the medical devices industry, we need to look at this as a tremendous opportunity to create the next generation of medical devices.
The current set of drugs, along with their toxicities, do very little. And, the one marketed medical device, the Lap Band, has proven its worth in treating obesity. But, the most important fact that needs to be soberly understood is that the little medical device company that invented that device was paid $1.2B by Allergan for it. Yes, that's a B.
One of the other very popular treatments for obesity, the vertical sleeve gastrectomy, uses several thousands of dollars of linear staples (Covidien, J&J) per procedure. Performed over a million times per year, you do the math.

Stein points to one startup that he is working with - Onciomed - that he believes has the potential to address the global obesity challenge. The Irvine, California firm has devised a minimally-invasive procedure called the GVS System that restricts food intake while providing a feeling of fullness and satiety. 
Fred Voss, another LinkedIn user who commented on the discussion, is also working on an innovative device to treat obesity while achieving the positive effects of bariatric surgery. San Clemente, California-firm PlenSat, where Voss is CEO, has developed what it calls digestible balloons. The capsules containing the balloons can be ingested over several days, thereby slowly changing stomach volume. They result in the patient feeling a sense of fullness.
The opportunity in treating obesity is not simply limited to startups though. Another LinkedIn user, Patrick Pickerell commented on how insurance reimbursement for devices used in obesity procedures as a result of AMA's decision is proving to be a boon to his company - Peridot. Pickerell is president of that firm based in Pleasanton, California.

My company (Peridot) is a supplier of precision metal and plastic components to the minimally invasive device companies. As such we have at least half a dozen clients in the stomach reduction space that have placed their bets on just such a ruling. Insurance reimbursement codes mean the difference between a viable exit/sale of these startups so from a business standpoint (somewhat selfishly I admit) I am glad for the ruling.
From an economic point of view it seems better to treat obesity now than pay for the long term effects of diabetes and heart disease.

Mexico surpasses US as world's most obese nation

Mexico surpasses US as world's most obese nation

The United States no longer holds the title of the world’s most populous, obese nation; that designation has been passed on to Mexico.

According to a new report from the United Nations, nearly 70 percent of Mexican adults are overweight, and childhood obesity in the country has tripled within the past decade, Medical Daily reported.  One-third of Mexican teenagers are also obese, and experts believe that four out of every five obese children will remain overweight for the rest of their lives.
Overall, 32.8 percent of Mexican adults are considered obese, compared to 31.8 percent of adults in the United States.  Nearly 70,000 deaths in Mexico each year are caused by weight-related diabetes, and more than 400,000 new cases of diabetes are diagnosed annually.
Experts believe the rise in Mexico’s obesity rates has to do with the continuously growing gap between the country’s classes, as 50 percent of the population currently lives below the poverty line.  According to Medical Daily, healthy diets are becoming less affordable, prompting individuals with low incomes to consume more unhealthy foods, such as fried foods and soda.
One researcher also believes the increase can be attributed to more Mexicans moving from rural to urban areas, where food prices are much higher and sedentary lifestyles are easier.
“The result is that for many Mexicans, particularly in urban areas or in northern states, switching to healthier diets is becoming increasingly difficult," UN expert Olivier de Shutter wrote in a report on Mexican agriculture and nutrition.

AMA Declares Obesity as Disease: Opens a new chapter in obesity treatment

 In July 2013 the American Medical Association declared that obesity was a disease.  Obesity and related healthcare issues cost the US $190 Billion annually.






This is an important time in the fight against obesity and diabetes

For the first time there is going to be a Obesity & Diabetes Innovation Summit in Orange County, California in Oct 3-4, 2013. 

10 Medical device and 10 pharma companies will be talking about their innovations in obesity and diabetes. Sponsor companies will get an opportunity to voice their support for obesity.

Who should attend:

 Medical device and pharmaceutical executives, business development executives (tremendous opportunity to partner with young start ups early).

Sponsor companies who are joining the fight against obesity.

Start up companies who can get tremendous visibility to investor and strategic partners

VCs, private investors, PE executives and boutique investment bankers as this new disease classification brings more opportunity in this space.

Doctors, Nutritional experts, medical device, pharma and hospital/healthcare executives, allied health care professionals.

To sponsor, showcase or qualify to present please email a non-confidential company profile to info.odis1@gmail.com

Top 20 in the obesity and diabetes space will be presenting at the innovation summit.

Obama will have to incentivise VCs to invest in life sciences and treat Obesity

We all know that Obama care will make it more expensive and we will pay more out of pocket to get treatment.
Obesity cost the nation $140 Billion annually.Obesity is the world's biggest market.

The policy makers can make it easy by incentivizing VCs to invest in Obesity technologies and in life science technologies. This will enable innovation or we will be paying more for royalties to international innovators.
WHITE HOUSE its up to you now!!!

Ultimately, Obamacare  may be able to offer healthcare to a wide array of people but may fail to remedy the ills of rising health insurance and healthcare costs. Meanwhile, in addition to taxes and penalties, the new entitlement program will be financed by more than $700 billion in cuts from Medicare over a ten year period. This means that retirees will need to buy additional supplemental insurance through one of the health care companies.

10 things Start up entrepreneurs need to know!

10 Important things any start up entrepreneur must know!

1. “Who needs a business plan?” Some startups think business plans are only for investors. In reality, you should do a business plan primarily for yourself, as it forces you to think through all the elements. If it’s not written down, you can’t measure it, and thus you can’t manage it. Also written plans are much more effective communication to your employees, lawyers, accountants, and other key players in your rollout.

2. “Once we build it, customers will come.” The hot term these days is “viral marketing”, meaning we won’t do any marketing, but our product is so great that everyone will know about us anyway by word of mouth and through Internet social networks. In most cases, viral marketing only begins to work after you prime the pump with several million in real marketing over a couple of years.
3. “We really have no competitors.” VCs and angel investors hear this one all the time. The investor view is that if you can’t find any competitors, either you are not being honest, or you haven’t looked, or there isn’t any market for your product. Your funding request will likely go into the circular file.
4. “Our product can do more than anyone.” Just because you included all the features of Facebook, Twitter, Pinterest, and LinkedIn in your new social networking product, doesn’t mean everyone will love it. In fact, quite the opposite usually happens, due to complexity and work to switch. Investors like laser focus on a market-need causing real pain.

5. “Big company is too big/slow to be a threat.” Usually the reason the big companies are no threat is that the market is too small. Competing with Large Company and other mid sized companies is a very difficult task. Entrepreneurs who utter this line are kidding themselves. They may think it’s bravado, but investors think it’s stupidity.

6. “We have the first-mover advantage.” That’s probably the soft way of saying, we don’t have a patent or any “secret sauce” for a competitive advantage. Unfortunately, a startup with no brand name and no intellectual property is a sitting duck for the big slow company, as soon as they see you gaining a bit of traction. Sleeping giants do wake up.


7. “We need to minimize our risk.” This is usually seen as the difference between involved and committed. Investors expect the founder and other principals to have “skin in the game,” over and above “sweat equity.” If you and your friends are trying to play Donald Trump, don’t expect other mere mortals to carry the risk load for you.

8.  “We’re funded, now we can relax.” Quite the opposite is really true. Now the real work starts to build a sustainable business. Now you have to manage to budgets and timelines, and avoid the temptation to splurge a bit on office space or too many new employees.

9. “It’s the market, stupid.” It’s great to have a passion about a favorite new toy you invented, but just because you love it doesn’t mean the whole world will love it. Another variation on this theme is the person who creates a “solution” from technology, and then makes up a “problem” that it will solve. There is no substitute for understanding the market, and sizing the opportunity, before you climb out on a limb.


10. “Me, myself, and I.”  a promising startup can wither and die for lack of funds because the founder may refused to consider stepping aside as CEO in favor of a more experienced candidate, as a condition of a $50M in Round C of VC investment. Best is to “kick yourself up to Chairman”, but some want it all, and let ego take precedence over good business sense.
You probably think these are so obvious that they are clichés. I wish that were true, but I still see them happening every day. The most successful startup founders are never too busy to listen to the market, listen to their advisors, stifle their ego, and enjoy the ride. It’s a lot more fun than the alternative.

When disruptive innovation appear, investors have learned, it’s time to act quickly!

VCs of today are risk averse and some private and international investors see this as a tremendous opporunity.
VCs risk averse attitude, this phenomenon is because of herd mentality, which has given the opportunity to private investors who were investing in traditional investments such as real estate, commercial properties and franchises to move their bets to young companies mainly in the life science medical device sector.
Start-up companies that are becoming successful are asking for larger multiples for their effort as a result the primary investors are making a big ROIs.
The startp-up CEOs are getting smarter, they are exiting earlier than usual, so the opportunity for VCs to get in late and reap bigger profits are gone.
CEOs are raising larger Seed or A rounds and exiting after accomplishing a decent milestone be it CE Mark or phase II clinical of a drug.
The new trend (Herd) for VCs is to impress (their LPs) with more deals for less money. Very little due diligence is going into these deals. In my opinion these are showcase deals, the chances of success is low, that is the reason they are available for cheap!. This strategy works in a way, VCs can downsize their organization yet hire their folks to run their new portfolio of failing companies (setting these new CEOs for failure instead of laying them off) and keep an eye on the company.. does this sound like a win-win or lose-lose for someone who has been with a VC firm for long.

Lets look at a unmet clinical need. Obesity and Diabetes.
In the 2000s, the timing of some VCs in the obesity and diabetes space was bad, the stringent FDA, clinical community still trying to figure out patho-physiology of obesity, companies targeting GI doctors with new technologies, while patient first comes to bariatric surgeon for treatment. Then there were a slew of technologies being inserted through the mouth with profiles as large as the esophagus, causing tears during insertion of the device into the stomach, with no opportunity to fix these problems with stand by surgeons...obviously there will be some challenges. Recently, newer technologies have emerged with great rationale to treat obesity and diabetes. But because few big name VCs are sitting on the sidelines, small boutique ventures are afraid to jump. Today obesity is the world's biggest market, US represent only a third of the market. Companies like Reshape, Obalon, Baronova, Onciomed, and GI Dynamics are the next gen technologies and have opportunities for jaw dropping exits.

Onciomed, Inc Raising Capital to Evaluate Obesity Technology in a Multi Billion Dollar Obesity & Diabetes Market.

Irvine, Calif.-based medical device company Onciomed, Inc., has received a U.S. patent to treat obesity and diabetes with a path-breaking minimally invasive procedure.
The medical device, GVS technology system, mimics gastric surgery without the need to cut the stomach and offers an alternative to highly invasive, irreversible bariatric surgery.
Great opportunity to be part of Onciomed.Inc
Contact: Raj@onciomed.com or info@onciomed.com

“We restrict the stomach and imitate the procedure similar to gastric bypass surgery, without cutting portions of the stomach,” said Onciomed founder and CEO Dr. Raj Nihalani, who developed the device.“This technology helps us get to the next level of intervention without doing much harm,” he told India-West.


Nihalani has worked for nearly 17 years in the medical device sector — where he focused on cardiology research, invented devices for coronary stents, and worked at start-ups including Endologix  ( acquired by larger company).
Nihalani said he was inspired to address major health issues not only in the U.S., but worldwide. His research led to his focus on obesity and diabetes, which he said is “one of the biggest healthcare markets in the world.”
Onciomed’s process involves a single incision laparoscopic procedure. Once in place, the GVS provides a feeling of “fullness and satiety” and reduces absorption of fat and glucose.
Nihalani noted that the company has the opportunity to expand to 20 additional patents. Currently, Onciomed is raising capital and inviting private investors to invest in its technologies. The goal is to do clinical trials outside the U.S, and eventually seek U.S. Food and Drug Administration approvals.
“With the invention of these novel products, what it does is it reduces the absorption of fat and glucose at the intestinal level which can help with diabetes prevention or reduce dependence. It can really help these patients not only lose weight, but correct diabetes status,” Nihalani said.
According to the World Health Organization, obesity has nearly doubled since 1980. In 2008, over 1.4 billion adults were overweight and more than half a billion were identified as obese. About 2.8 million people die from conditions related to being overweight or obese, the WHO said. More than one-third of adults in the U.S. and about 17% (12.5 million) children between the ages of 2-19 are obese, according to the Centers for Disease Control and Prevention.
“What we are working on is a very novel technology. We feel that this is the next big thing in the healthcare field, and I’m glad that I am one of the first Indians to get patents in the obesity and diabetes phase,” Nihalani told India-West.
A study, “South Asian American Perspectives on Overweight, Obesity, and the Relationship Between Weight and Health,” was recently published through the CDC. It looked at the effects of health and weight among South Asian Americans by interviewing 75 South Asian Americans and measuring their BMI (body mass index). About 67% of the participants in the study were identified as overweight or obese and about 82% of those who were obese believed their weight affected their health, according to the study.
South Asians have higher risks for both cardiovascular disease and Type 2 Diabetes than do most other ethnic groups, the study noted.
“Among all Asians in the United States, South Asians have the highest rates of overweight and obesity,” the study said.
Children are also at risk for diabetes and obesity, especially with dietary changes and accessibility to junk food and carbonated drinks. “For South Asian children, 14 percent are obese. It’s lower than the general U.S. population, but yet there is a tendency to be obese,” Nihalani said.
The Indian American entrepreneur explained that in recent years the size of portions offered to children at schools has dramatically changed. “How we eat and the way we eat has changed. Obesity trends have increased in the last two decades. Portions (children) are offered and complex carbohydrates have drastically affected wave points. It won’t end, so this is going to be a very big issue," he asserted.
“One in six kids is obese in the United States and one in 10 kids is obese in the South Asian population,” he emphasized.
Nihalani hopes to focus in the future on addressing childhood obesity and set aside a portion of the profits in his current venture towards that goal.
“I want to focus on how to connect the two worlds on the healthcare front and the ones in developing countries — how to connect the knowledge and infrastructure here and how to integrate that for healthcare," he said.

Read more at http://www.indiawest.com/news/10077-onciomed-patents-minimally-invasive-obesity-treatment.html?goback=%2Egmp_2136343%2Egde_2136343_member_230290831#UOcVOweGMGmBoQ7M.99